Abstract

Latent tuberculosis infection (LTBI) management is now a critical component of the End TB Strategy. In this randomised controlled trial (ChiCTR-IOR-15007202), two short-course regimens with rifapentine plus isoniazid, the 3-month once-weekly regimen and the 2-month twice-weekly regimen, were initially designed to be evaluated for 50–70 years aged rural residents with LTBI in China. Due to the fast-growing occurrence of adverse effects, the treatments were early terminated after 8 weeks for once-weekly regimen and after 6 weeks for twice-weekly regimen, respectively. In the modified intention-to-treat analysis on the completed doses, cumulative rate of active disease during 2 years follow-up was 1.21% (14/1155) in the untreated controls, 0.78% (10/1284) in the group of 8-week once-weekly regimen, and 0.46% (6/1299) in the group of 6-week twice-weekly regimen. The risk of active disease was decreased with adjusted hazard ratio of 0.63 (95% CI, 0.27–1.43) and 0.41 (95% CI, 0.15–1.09) for the treatments, respectively. No significant difference was found in the occurrence of hepatotoxicity, 1.02% (13/1279) versus 1.17% (15/1279) (p=0.704). The short regimens tested must be used with caution among elderly because of the high rates of adverse effects. Further work is necessary to test the ultra-short regimens in younger people with LTBI.

Footnotes

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

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